磺达肝癸钠对COPD、肺癌、ILD、老年肺炎患者VTE干预作用：多中心、随机、对照研究

Effect of Fondaparinux Sodium on VTE in COPD, Lung Cancer, ILD and Elderly Patients with Pneumonia: A Multicenter, Randomized, Controlled Study

摘要: 目的：观察磺达肝癸钠对于4种易合并静脉血栓栓塞症(Venous Thromboembolism, VTE)高风险的呼吸系统疾病(肺癌、慢性阻塞性肺疾病、间质性肺疾病、老年肺炎)患者预防其静脉血栓栓塞(VTE)事件的安全性和有效性。方法：选取2020年11月至2021年10月于多家中心入院的VTE高风险呼吸系统疾病患者217例，随机将其分配至磺达肝癸钠组(105例)和低分子肝素组(112例)。磺达肝癸钠组应用国产磺达肝癸钠治疗(2.5 mg/天，用药7天)，低分子肝素组应用依诺肝素治疗(4000 AxaIU/天，用药7天)。观察两组患者用药后7天内及1月内出血事件与血栓事件发生率。结果：磺达肝癸钠组7天血栓事件发生率低于低分子肝素组(0比5.4%, p < 0.05)，磺达肝癸钠组7天出血事件发生率与低分子肝素组无统计学差异(0比4.5%, p > 0.05)，磺达肝癸钠组30天血栓事件发生率(0比8.9%, p < 0.05)及出血事件发生率(0比5.4%, p < 0.05)均低于低分子肝素组。结论：应用磺达肝癸钠预防呼吸系统疾病患者静脉血栓栓塞事件具有较好的有效性和安全性，可推广应用。

Abstract: Objective: To observe the safety and efficacy of fondaparinux sodium in preventing venous throm-boembolism (VTE) in patients with four respiratory diseases (lung cancer, chronic obstructive pul-monary disease, interstitial lung disease and senile pneumonia) prone to high risk of VTE. Methods: 217 patients with VTE high-risk respiratory diseases admitted to several medical centers from No-vember 2020 to October 2021 were randomly assigned to fondaparinux sodium group (105 cases) and low molecular weight heparin group (112 cases). The fondaparinux group was treated with fondaparinux sodium (2.5 mg/day, 7 days), and the low molecular weight heparin group was treat-ed with enoxaparin sodium (4000 AxaIU/day, 7 days). The incidence of bleeding events and thromboembolic events within 7 days and 1 month was observed. Results: The incidence of 7-day thrombotic events in fondaparinux group was lower than that in LMWH group (0 vs 5.4%, p < 0.05), the incidence of 7-day bleeding events in fondaparinux group was not significantly different from that in LMWH group (0 vs 4.5%, p > 0.05), and the incidence of 30 day thrombotic events (0 vs 8.9%, p < 0.05) and bleeding events (0 vs 5.4%, p < 0.05) in fondaparinux group was lower than those in LMWH group. Conclusion: Using fondaparinux sodium to prevent venous thromboembolism in pa-tients with respiratory diseases has obvious effectiveness and higher safety, which can be recom-mended.